Associate Director, Regulatory Affairs

Reports to Regulatory Operations (RegOps) Director in OPAR.

The RegOps Associate Director is responsible for the review, approval, and oversight of regulatory submissions to the promotional review divisions of FDA (OPDP/APLB) for all U.S. products. Ensures regulatory submissions are aligned with FDA regulations and our Company standards. 

Functions as a point of contact for operational activities and coordinates with other Regulatory Affairs teams, including Publishing, Information Management, Data Sciences, and Regulatory Affairs Functions.

Develops analytics, reports, and dashboards; leverages predictive modeling to identify trends and insights; and prepares quarterly metrics to track operational performance.

Provides direction and performance management for a team of contractors supporting the submission of promotional materials to FDA. 

Partners with commercial teams and stakeholders and proposes creative solutions for complex regulatory submissions and provides the required technological and operational expertise needed to make rapid and compliant decisions aligned with business objectives.

Maintains knowledge of evolving FDA regulations and submission criteria for different types of promotion communications and materials, ensures our Company standards and processes are in alignment.

Supports activities generated from the Human Health Promotion Quality Management program to ensure materials are of high quality and comply with FDA and our Company standards, guidelines and regulations. Supports deviation investigations and corrective actions and strives to make the process more efficient.  

• Minimum Requirement:  B.A. or B.S. degree

• Minimum 5 years’ experience in the pharmaceutical industry supporting the promotional review process or similar experience in Quality Assurance and/or Regulatory Submission Management, Regulatory Publishing, Submission planning and filing of materials with FDA or health authorities.
•  Proficiency with Veeva PromoMats software workflows and reports.
•  Proficiency with data reporting software and GenAI tools and agents, including PowerBI, Whiteboard, Copilot, GPT, Google Gemini.
•  Excellent project management skills and ability to plan and prioritize submission work in a fully digital-enabled promotional environment to effectively support business critical activities.
•  Understanding of FDA regulations, processes and systems relating to advertising and promotion for prescription products.
•  Strong interpersonal and negotiation skills and the ability to demonstrate strategic and analytic thinking
•  Demonstrated ability to negotiate and influence others effectively.
•  Proactive and solution-oriented, with the ability to manage multiple priorities simultaneously.

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.